Paradigm Spine, LLC Announces the Release of Two Independent Prospective Clinical Studies that Substantiate coflex? Interlaminar Stabilization After Decompression for the Treatment of Spinal

ADVERTISEMENT

See our 2013 Buyers Guide Digital Edition.
Paradigm Spine, LLC Announces the Release of Two Independent Prospective Clinical Studies that Substantiate coflex? Interlaminar Stabilization After Decompression for the Treatment of Spinal Stenosis


Paradigm Spine, LLC Announces the Release of Two Independent Prospective Clinical Studies that Substantiate coflex® Interlaminar Stabilization After Decompression for the Treatment of Spinal Stenosis

PR Newswire

NEW YORK, July 8, 2014 /PRNewswire/ -- Paradigm Spine, LLC, a leading provider of innovative motion preserving spinal publication of two separate independent prospective clinical research studies that address clinical effectiveness of open surgical decompression or laminotomy, and the effect of post decompression interlaminar stabilization including validated outcomes parameters and supportive imaging measurements to convincingly support the improved short term and long term durability of coflex® interlaminar stabilization.

In the recently published study titled "Role of coflex as an Adjunct to Decompression for Symptomatic Lumbar Spinal Stenosis" in the Asian Spine Journal, April 8, 2014, Dr. Naresh Kumar, et al used a prospective and patient randomized cohort comparison study of decompression alone vs decompression supplemented with the addition of coflex® interlaminar stabilization looking at patient reported outcomes and the correlation of these outcomes to imaging over two years after surgery.  The authors noted statistically significant clinical outcome improvement over preoperative status with open surgical decompression and also noted the addition of coflex® statistically improved the outcomes over the decompression only group.  Postoperative imaging studies supported statistically significant maintenance of disc heights and foraminal heights with interlaminar stabilization compared to the decompression only group.[1]

In a separate publication, "coflex Dynamic Distraction Stabilization Device for Lumbar Degenerative Diseases" published in Cureus, January 2, 2014 by Mohamed Mohi Eldin discusses a multicenter prospective case controlled series that reveals significant improvement in patient reported outcomes including back pain improvement and functional stabilization of disc heights and foraminal volume with maintenance of dynamic motion at the index level of surgery.[2]

As these two important independent studies continue to add to the wealth of published literature worldwide, Marc Viscogliosi, Chairman and CEO of Paradigm Spine, LLC comments, "critical thinking from clinicians throughout the world will help determine the true place for this innovative technology and we are pleased to see studies from different parts of the world contributing to the massive evidence library for coflex® interlaminar stabilization." 

From a patient advocate and surgeon's perspective, Hallett Mathews, MD, MBA, EVP & CMO is impressed with the improved performance of decompressions that are supplemented with the coflex® device.  "Surgeons appreciate the effectiveness of surgical decompression, however we have seen little long term evidence on how these decompressions perform with progressive degenerative disease causing spinal stenosis.  Dr. Kumar's work shows the importance of decompression, and statistically favorable outcomes, that were markedly improved with the addition of coflex® stabilization.  The improved initial results and the durability of the symptom relief at 2 years is impressive.  Simple decompression results without the addition of coflex® were not always sustainable over time.  Interlaminar stabilization clearly leads to improved patient outcomes and value."

About Paradigm Spine, LLC

Paradigm Spine, LLC was founded in 2004 and remains focused on the design and development of solutions for the disease management of spinal stenosis. The Company's signature product is the coflex® interlaminar stabilization device, which has more than 20 years of clinical history and patients treated in more than 40 countries worldwide.

[1] "Role of coflex as an Adjunct to Decompression for Symptomatic Lumbar Spinal Stenosis" Naresh Kumar, et al, Asian Spine J. 2014 Apr; 8 (2):161-169.

[2] "coflex Dynamic Distraction Stabilization Device for Lumbar Degenerative Diseases" Mohamed Mohi Eldin (2014-01-02 18:00:00 UTC) Cureus 6(1): e152. doi:10.7759/cureus.152

SOURCE Paradigm Spine, LLC

ADVERTISEMENT

blog comments powered by Disqus

ADVERTISEMENT

UPCOMING CONFERENCES

8th Annual Forum on Transparency and Aggregate Spend 2014
Washington, DC
August 18-20, 2014

eSource Data in Clinical Investigations
Philadelphia, PA
August 20-21, 2014

Pharmacovigilance 2014
Philadelphia, PA
September 10-11, 2014

Collaborative Research Summit
Philadelphia, PA
October 15-16, 2014

See All Conferences >>

Survey
As it creates a plan to implement the US biosimilar pathway, should FDA:
Borrow heavily from EMA's pathway program?
Borrow lightly from EMA's pathway program?
Create entirely its own pathway program?
Borrow heavily from EMA's pathway program?
86%
Borrow lightly from EMA's pathway program?
7%
Create entirely its own pathway program?
7%
View Results
Untitled Document

Click here